Quarterly IRB Newsletters
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Change in IRB Process for Informed Consent Documents - No Site Name and Site Address Required - Effective October 1, 2015 IntegReview will no longer require the study site names/addresses to be included in the informed consent document (ICD). There is no federal regulatory or AAHRPP requirement that requires the inclusion of study site names/addresses to be included in the ICD.
This IRB process change will streamline the processes involved with ICDs and will assist in our obligation to provide you with a more expedient turn-around of your documents. The ICD will continue to include the name of the Principle Investigator and the site contact number.
IntegReview IRB process effective October 1, 2015:
When site names/addresses are included in new ICFs they will be removed. Please refer to our Sample IC templates available on our website for information on IRB requirements. In addition, the informed consent(s) will be updated to remove site names/addresses upon any requested change to the informed consent or at the time of Continuing Review, as applicable.
IntegReview IRB Changes Address - IntegReview moved to a new location in July 2015. The new mailing address is: 3815 S. Capital of Texas Hwy, Suite 320, Austin, TX 78704.
"DRAFT" FDA Guidance - Use of Electronic Consent in Clinical Investigations - This draft guidance document, distributed in March 2015, provides recommendations for clinical investigators, sponsors, and IRBs on the use of electronic media and processes to obtain informed consent. FDA's requirements for electronic records/ signatures, informed consent, and IRBs are set forth in 21 CFR parts 11, 50, and 56, respectively. The information presented to the subject, processes used for obtaining informed consent, and documentation of the electronic informed consent (eIC) must meet the requirements of these and other applicable regulations. [READ MORE]
IntegReview Expands IRB Oversight of Clinical Research to Japan - Effective March 19, 2015, IntegReview extended its IRB oversight to sites located in Japan. This review applies to research that is governed by a U.S. federal agency and a local Consultant will be utilized to assist in the IRB review. Call us to learn more about this new service at 512-326-3001.
May 28, 2019: IntegReview IRB is Pleased to Announce the Latest FDA Routine Audit Finds No Deficiencies
In the past 20 years, IntegReview IRB has experienced four (4) routine inspections from The U.S. Food and Drug Administration (FDA) of their policies and procedures relating to the protection of human subjects in research. The fourth inspection recently occurred on May 20-22, 2019.
“We are pleased to announce that the most recent FDA audit has resulted in no findings or concerns; no deficiencies were observed, and no issuance of a FDA Form 483. We are so very appreciative of our IRB Staff and IRB Members that contributed to the success of this inspection. IntegReview IRB will continue to dedicate the highest ethics and attention to detail to the oversight of research and to the protection of subjects,” said Melissa Meyer, CCRP, President.
“IntegReview IRB is proud of the successful outcome of the inspection and we applaud the performance of our Compliance team and all of our staff who collectively contribute to our Quality Management Program,” said Melanie Flores, CIP, CCRP, Vice President of Compliance.
IntegReview IRB is an AAHRPP-accredited independent IRB based in Austin, Texas. It is a certified woman-owned business and is celebrating its 20th anniversary. IntegReview provides exemplary quality-driven ethical review (IRB services) for pharma, medical device, biotech and researchers across the U.S., Latin America and Japan.
July 11, 2018: IntegReview IRB Adds Renowned Professor Emeritus to Team
IntegReview IRB announces that Ernest D. Prentice, Ph.D. has joined the organization as a Senior Consultant to the IRB. In his new role, Dr. Prentice will work with IntegReview leadership to provide consultation to the IRB and educate researchers by speaking at upcoming research conferences. “We are thrilled to work with someone as experienced and knowledgeable as Dr. Prentice,” said Melissa Meyer, CCRP, President of IntegReview IRB. “He has an incredible, respected reputation from his work at the Department of Genetics, Cell Biology and Anatomy at the University of Nebraska Medical Center [Professor Emeritus]. With his background and involvement with Institutional based and Central IRBs, we are honored for him to join the IntegReview team.”
May 16, 2017: IntegReview IRB and Veritas IRB announce partnership to provide accredited ethics review services in the U.S. and Canada
IntegReview IRB partnered with Canadian-based Veritas IRB Inc., to provide ethics review services and risk management consulting to sponsors of research and investigators in both the United States and Canada. Through their combined efforts, IntegReview IRB and Veritas IRB will ensure a seamless and comprehensive review in full compliance with regulatory and ethical requirements in both countries. The partnership allows IntegReview IRB to have a strategic geographic presence in order to provide to its clients with seamless high quality services and human research protections oversight for research participants in the United States and Canada.
September 25, 2015: IntegReview IRB Receives Reaccreditation from AAHRPP
IntegReview IRB announces its reaccreditation by the Association for the Accreditation of Human Research Protection Programs, Inc.® (AAHRPP).
“IntegReview IRB is proud to receive reaccreditation from AAHRPP,” says Melissa Meyer, CCRP, Vice President. “Our company continues to strive to bring exemplary customer support to our clients while providing the highest standard of ethical review to research projects.” [READ MORE]
September 14, 2015: IntegReview IRB Announces Move to New Location
IntegReview IRB officially announced their move to a new location along Austin’s beautiful Barton Creek Greenbelt, located at 3815 S. Capital of Texas Hwy, Ste. 320, Austin, TX 78704. “We are thrilled to be in our brand new office,” says Melissa Meyer, Vice President at IntegReview IRB. “Our team designed a forward-thinking, environmentally-friendly layout to create a great working atmosphere for our employees. Our expansion will allow us to meet the increasing clinical research needs of our clients.” [READ MORE]
May 21, 2015: IntegReview IRB and Verified Clinical Trials have developed a preferred partnership to stop dual enrollment in clinical trials and reduce protocol deviations while promoting safety. [READ MORE]
2019 Upcoming Events
|Sept 27-29||SOCRA||San Antonio, TX||Attendee / Training|
|Nov 18-20||PRIM&R||Boston, MA||Attendee / Training|
Additional conferences (exhibitor and attendence) will be updated shortly.